To assess the efficacy and patient safety of (1)fractional laser treatment in combination with NB- UVB,(2) fractional laser treatment in combination with NB- UVB and topical corticosteroids versus NB-UVB treatment alone.
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint:
Objective assessment of the degree of repigmentation 6 months after the first
fractional laser therapy. Assessment will be done on sheets, using a digital
image analysis system. Software based on Matlab will be used to analyse the
images and to calculate the depigmented surface. By comparing pre- and post
treatment images, the surface showing repigmentation can be computed.
Secondary outcome
Secondary study parameters/endpoints:
- Visual assessment of side effects per treatment region (hyperpigmentation,
hypo- pigmentation and scar formation on a scale from 0-3) will be done by a
blinded investigator.
- General outcome will be assessed by the patient and physician per treatment
region on a scale from 0-3
- Colour difference i.e. the difference between erythema and pigmentation will
be assessed with a Derma-spectrometer
Background summary
Vitiligo is a common skin disorder that can impair a patient*s quality of life.
Many depigmented lesions in vitiligo patients remain therapy resistant for
medical treatment. Therefore new therapeutic options in these patients are
necessary. Currently, dermabrasion by conventional or fractional laser therapy
in combination with NB-UVB therapy and steroids appears to be effective in
therapy resistant areas. However, little literature on this combination is
available.
Study objective
To assess the efficacy and patient safety of (1)fractional laser treatment in
combination with NB- UVB,(2) fractional laser treatment in combination with NB-
UVB and topical corticosteroids versus NB-UVB treatment alone.
Study design
Prospective observer blinded randomised intra-patient controlled study.
Intervention
Three NB-UVB resistant depigmented regions on the trunk or extremities will be
randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2
laser abrasion, or (2)NB-UVB treatment in combination with fractional CO2 laser
abrasion and topical steroids, or (3)NB-UVB treatment alone. NB-UVB treatment
and topical steroids will be given according to the standard treatment protocol
of the SNIP and continued for at least 6 months and 6 months after the first
laser treatment, the percentage of repigmentation of the lesions will be
assessed.
Study burden and risks
Patients will not miss any regular treatment. The study involves depigmented
lesions which are therapy resistant to current NB-UVB treatment. The time
investment for the patient will be approximately 75 minutes for the intake
including the first laser treatment and half an hour for the follow up visits.
Side effects: infection in the treated area may occur but is rare and the risk
of scarring is very low. Although erythema of the laser-treated areas does
occur often, this is generally temporary. In case of improvement of the
depigmentation, the most efficacious treatment modality will be offered to
treat the whole depigmented skin area.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
- Patients with non segmental (generalised) vitiligo visiting the Netherlands Institute for Pigment Disorders
- receiving NB- UVB treatment for 3 to 6 months
- Age >18 years
- At least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm.
- Patient is willing and able to give written informed consent
Exclusion criteria
- Skin type I
- Recurrent HSV skin infections
- Hypertrophic scars
- Keloid
- Cardial insufficiency
- Patients who are pregnant or breast-feeding
- Patients not competent to understand what the procedures involved
- Patients with a personal history of melanoma or non-melanoma skin cancer
- Patients with atypical nevi.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45970.018.13 |